Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to OECD guideline study. Acceptable, well documented report which meets basic scientific principles. Study was conducted before establishment of the OECD Test Guideline, but study protocol is in principle similar to OECD TG 405, with acceptable restrictions (only 50 µL instilled, only 2 animals used, observation period only 8 days).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Only 50 µL instilled, only 2 animals used, observation period only 8 days.
Principles of method if other than guideline:
Standardized test method (BASF-Test)
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 50 µL of the test substance were applied to the conjunctival sac of one eye each in 2 animals. The saline-treated adjacent eye served as control. The animals were observed after 10 min, 1 and 3 h on the day of treatment and daily up to 8 days afterwards. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aethylpiperidin
- Physical state: liquid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.97 kg (male) and 2.99 kg (female)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

READING: 10 min, 1, 24, 48 and 72 h and 8 days

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: staphyloma
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Animal 1 exhibit white nictitating membrane 72 hours after instllation; additionally, scar formation at the eye lid and alopecia in the surrounding region.
Animal 2 exhibit purulence and grey corroded nictitating membrane 72 hours after treatment; additionally, a staphyloma after 8 days as well as crusta at the eye lid and alopecia in the surrounding region.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

 

Rabbit #

Time [h]

conjunctivae 

iris

cornea

remarks 

redness

swelling

1

10 min

2

1

0

3

 

1 h

2

1

0

3

 

3 h

2

2

0

3

 

24 h

2

2

0

3

 

48 h

2

2

0

3

 

72 h

2

2

2

3

 

8 days

2

2

2

3

eyelid scar

average

2.0

2.0

0.7

3.0

 

2

10 min

2

0

0

3

 

1 h

2

0

0

3

 

3 h

0

0

0

0

 

24 h

2

2

0

0

 

48 h

2

2

0

0

 

72 h

0

2

0

0

 purulence

8 days

0

0

0

0

staphyloma

average

1.3

2.0

0.0

0.0

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information